Trial Outcomes & Findings for Neonates and Azithromycin, an Innovation in the Treatment of Children in Burkina Faso (NCT NCT03682653)
NCT ID: NCT03682653
Last Updated: 2023-06-27
Results Overview
The primary outcome of the study was all-cause mortality rate in infants at 6 months of age.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
21832 participants
Primary outcome timeframe
6 months
Results posted on
2023-06-27
Participant Flow
Participant milestones
| Measure |
Azithromycin
a single dose of Azithromycin will be administered to infants between their 8-27th days of life
Azithromycin: a single dose of Azithromycin will be administered to infants between their 8-27th days of life
|
Placebo
a single dose of placebo will be administered to infants between their 8-27th days of life
Placebo: a single dose of Placebo will be administered to infants between their 8-27th days of life
|
|---|---|---|
|
Overall Study
STARTED
|
10898
|
10934
|
|
Overall Study
Received Allocated Treatment
|
10898
|
10928
|
|
Overall Study
Day 21
|
10069
|
10119
|
|
Overall Study
3 Months
|
10273
|
10356
|
|
Overall Study
COMPLETED
|
9606
|
9684
|
|
Overall Study
NOT COMPLETED
|
1292
|
1250
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Azithromycin
n=10898 Participants
a single dose of Azithromycin will be administered to infants between their 8-27th days of life
Azithromycin: a single dose of Azithromycin will be administered to infants between their 8-27th days of life
|
Placebo
n=10934 Participants
a single dose of placebo will be administered to infants between their 8-27th days of life
Placebo: a single dose of Placebo will be administered to infants between their 8-27th days of life
|
Total
n=21832 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
11 days
n=10898 Participants
|
11 days
n=10934 Participants
|
11 days
n=21832 Participants
|
|
Sex: Female, Male
Female
|
5413 Participants
n=10898 Participants
|
5431 Participants
n=10934 Participants
|
10844 Participants
n=21832 Participants
|
|
Sex: Female, Male
Male
|
5485 Participants
n=10898 Participants
|
5503 Participants
n=10934 Participants
|
10988 Participants
n=21832 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Burkina Faso · Center
|
919 Participants
n=10898 Participants
|
951 Participants
n=10934 Participants
|
1870 Participants
n=21832 Participants
|
|
Region of Enrollment
Burkina Faso · Boucle du Mouhoun
|
1299 Participants
n=10898 Participants
|
1329 Participants
n=10934 Participants
|
2628 Participants
n=21832 Participants
|
|
Region of Enrollment
Burkina Faso · Cascade
|
2009 Participants
n=10898 Participants
|
1977 Participants
n=10934 Participants
|
3986 Participants
n=21832 Participants
|
|
Region of Enrollment
Burkina Faso · Center Ouest
|
1217 Participants
n=10898 Participants
|
1211 Participants
n=10934 Participants
|
2428 Participants
n=21832 Participants
|
|
Region of Enrollment
Burkina Faso · Hauts-Bassins
|
5454 Participants
n=10898 Participants
|
5465 Participants
n=10934 Participants
|
10919 Participants
n=21832 Participants
|
|
Region of Enrollment
Burkina Faso · Missing
|
0 Participants
n=10898 Participants
|
1 Participants
n=10934 Participants
|
1 Participants
n=21832 Participants
|
|
Urban dwelling
Urban
|
8960 Participants
n=10898 Participants
|
9055 Participants
n=10934 Participants
|
18015 Participants
n=21832 Participants
|
|
Urban dwelling
Rural
|
1932 Participants
n=10898 Participants
|
1869 Participants
n=10934 Participants
|
3801 Participants
n=21832 Participants
|
|
Urban dwelling
Missing
|
6 Participants
n=10898 Participants
|
10 Participants
n=10934 Participants
|
16 Participants
n=21832 Participants
|
|
Season of enrollment
Rainy (June to October)
|
5217 Participants
n=10898 Participants
|
5295 Participants
n=10934 Participants
|
10512 Participants
n=21832 Participants
|
|
Season of enrollment
Dry (November to May)
|
5681 Participants
n=10898 Participants
|
5639 Participants
n=10934 Participants
|
11320 Participants
n=21832 Participants
|
|
Birthweight
|
3000 g
n=10898 Participants
|
3000 g
n=10934 Participants
|
3000 g
n=21832 Participants
|
|
Weight at enrollment
|
3300 g
n=10898 Participants
|
3300 g
n=10934 Participants
|
3300 g
n=21832 Participants
|
|
Length at enrollment
|
50.4 cm
n=10898 Participants
|
50.5 cm
n=10934 Participants
|
50.5 cm
n=21832 Participants
|
|
Wasted
|
531 Participants
n=10898 Participants
|
559 Participants
n=10934 Participants
|
1090 Participants
n=21832 Participants
|
|
Underweight
|
658 Participants
n=10898 Participants
|
652 Participants
n=10934 Participants
|
1310 Participants
n=21832 Participants
|
|
Stunted
|
884 Participants
n=10898 Participants
|
869 Participants
n=10934 Participants
|
1753 Participants
n=21832 Participants
|
|
MUAC
|
10.9 cm
n=10898 Participants
|
11.0 cm
n=10934 Participants
|
11.0 cm
n=21832 Participants
|
|
Mother's age
|
25 years
n=10898 Participants
|
25 years
n=10934 Participants
|
25 years
n=21832 Participants
|
|
Mother's education
None
|
5910 Participants
n=10898 Participants
|
6029 Participants
n=10934 Participants
|
11939 Participants
n=21832 Participants
|
|
Mother's education
Primary
|
1990 Participants
n=10898 Participants
|
1978 Participants
n=10934 Participants
|
3968 Participants
n=21832 Participants
|
|
Mother's education
Secondary or above
|
2997 Participants
n=10898 Participants
|
2923 Participants
n=10934 Participants
|
5920 Participants
n=21832 Participants
|
|
Mother's education
Missing
|
1 Participants
n=10898 Participants
|
4 Participants
n=10934 Participants
|
5 Participants
n=21832 Participants
|
|
No. children in household
|
1 children
n=10898 Participants
|
1 children
n=10934 Participants
|
1 children
n=21832 Participants
|
|
Pregnancy type
Singleton
|
10702 Participants
n=10898 Participants
|
10753 Participants
n=10934 Participants
|
21455 Participants
n=21832 Participants
|
|
Pregnancy type
Multiple
|
195 Participants
n=10898 Participants
|
177 Participants
n=10934 Participants
|
372 Participants
n=21832 Participants
|
|
Pregnancy type
Missing
|
1 Participants
n=10898 Participants
|
4 Participants
n=10934 Participants
|
5 Participants
n=21832 Participants
|
|
No. of antenatal visits
|
4 visits
n=10898 Participants
|
4 visits
n=10934 Participants
|
4 visits
n=21832 Participants
|
|
Initiation of breastfeeding
Immediate
|
10320 Participants
n=10898 Participants
|
10341 Participants
n=10934 Participants
|
20661 Participants
n=21832 Participants
|
|
Initiation of breastfeeding
Delayed
|
566 Participants
n=10898 Participants
|
574 Participants
n=10934 Participants
|
1140 Participants
n=21832 Participants
|
|
Initiation of breastfeeding
Not breastfeeding
|
11 Participants
n=10898 Participants
|
15 Participants
n=10934 Participants
|
26 Participants
n=21832 Participants
|
|
Initiation of breastfeeding
Missing
|
1 Participants
n=10898 Participants
|
4 Participants
n=10934 Participants
|
5 Participants
n=21832 Participants
|
PRIMARY outcome
Timeframe: 6 monthsThe primary outcome of the study was all-cause mortality rate in infants at 6 months of age.
Outcome measures
| Measure |
Azithromycin
n=9606 Participants
a single dose of Azithromycin will be administered to infants between their 8-27th days of life
Azithromycin: a single dose of Azithromycin will be administered to infants between their 8-27th days of life
|
Placebo
n=9684 Participants
a single dose of placebo will be administered to infants between their 8-27th days of life
Placebo: a single dose of Placebo will be administered to infants between their 8-27th days of life
|
|---|---|---|
|
6 Month Mortality - All Cause
|
42 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: 12 monthsAll-cause Mortality Rate in infants at 12 months of age
Outcome measures
| Measure |
Azithromycin
n=9534 Participants
a single dose of Azithromycin will be administered to infants between their 8-27th days of life
Azithromycin: a single dose of Azithromycin will be administered to infants between their 8-27th days of life
|
Placebo
n=9563 Participants
a single dose of placebo will be administered to infants between their 8-27th days of life
Placebo: a single dose of Placebo will be administered to infants between their 8-27th days of life
|
|---|---|---|
|
12 Month Mortality - All Cause
|
52 Participants
|
64 Participants
|
SECONDARY outcome
Timeframe: 12 monthsCaregivers will be asked if the child is dead or alive at 365 days of life
Outcome measures
| Measure |
Azithromycin
n=9534 Participants
a single dose of Azithromycin will be administered to infants between their 8-27th days of life
Azithromycin: a single dose of Azithromycin will be administered to infants between their 8-27th days of life
|
Placebo
n=9563 Participants
a single dose of placebo will be administered to infants between their 8-27th days of life
Placebo: a single dose of Placebo will be administered to infants between their 8-27th days of life
|
|---|---|---|
|
Vital Status
|
52 Participants
|
64 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 1 missing weight measure at baseline in placebo arm.
Weight gain from baseline to day 180
Outcome measures
| Measure |
Azithromycin
n=9475 Participants
a single dose of Azithromycin will be administered to infants between their 8-27th days of life
Azithromycin: a single dose of Azithromycin will be administered to infants between their 8-27th days of life
|
Placebo
n=9626 Participants
a single dose of placebo will be administered to infants between their 8-27th days of life
Placebo: a single dose of Placebo will be administered to infants between their 8-27th days of life
|
|---|---|---|
|
Change in Weight Over Time
|
23.2 g/day
Standard Deviation 5.3
|
23.3 g/day
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 4 missing length measures at baseline. All in placebo arm.
Change in length from baseline to day 180
Outcome measures
| Measure |
Azithromycin
n=9475 Participants
a single dose of Azithromycin will be administered to infants between their 8-27th days of life
Azithromycin: a single dose of Azithromycin will be administered to infants between their 8-27th days of life
|
Placebo
n=9623 Participants
a single dose of placebo will be administered to infants between their 8-27th days of life
Placebo: a single dose of Placebo will be administered to infants between their 8-27th days of life
|
|---|---|---|
|
Change in Length Over Time
|
0.9 mm/day
Standard Deviation 0.2
|
0.9 mm/day
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: 8 weeksProportion of infants developing infantile hypertrophic pyloric stenosis between 2 to 8 weeks after treatment
Outcome measures
| Measure |
Azithromycin
n=10898 Participants
a single dose of Azithromycin will be administered to infants between their 8-27th days of life
Azithromycin: a single dose of Azithromycin will be administered to infants between their 8-27th days of life
|
Placebo
n=10934 Participants
a single dose of placebo will be administered to infants between their 8-27th days of life
Placebo: a single dose of Placebo will be administered to infants between their 8-27th days of life
|
|---|---|---|
|
Proportion of Infants Developing Infantile Hypertrophic Pyloric Stenosis
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 monthsCaregivers will be asked if their child experienced any symptoms for pyloric stenosis since the last visit.
Outcome measures
| Measure |
Azithromycin
n=9634 Participants
a single dose of Azithromycin will be administered to infants between their 8-27th days of life
Azithromycin: a single dose of Azithromycin will be administered to infants between their 8-27th days of life
|
Placebo
n=9643 Participants
a single dose of placebo will be administered to infants between their 8-27th days of life
Placebo: a single dose of Placebo will be administered to infants between their 8-27th days of life
|
|---|---|---|
|
Adverse Events
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 28 daysMortality prior to 28 days of life
Outcome measures
| Measure |
Azithromycin
n=10485 Participants
a single dose of Azithromycin will be administered to infants between their 8-27th days of life
Azithromycin: a single dose of Azithromycin will be administered to infants between their 8-27th days of life
|
Placebo
n=10547 Participants
a single dose of placebo will be administered to infants between their 8-27th days of life
Placebo: a single dose of Placebo will be administered to infants between their 8-27th days of life
|
|---|---|---|
|
Neonatal Mortality
|
9 Participants
|
6 Participants
|
Adverse Events
Azithromycin
Serious events: 29 serious events
Other events: 575 other events
Deaths: 52 deaths
Placebo
Serious events: 15 serious events
Other events: 599 other events
Deaths: 64 deaths
Serious adverse events
| Measure |
Azithromycin
n=10898 participants at risk
a single dose of Azithromycin will be administered to infants between their 8-27th days of life
Azithromycin: a single dose of Azithromycin will be administered to infants between their 8-27th days of life
|
Placebo
n=10934 participants at risk
a single dose of placebo will be administered to infants between their 8-27th days of life
Placebo: a single dose of Placebo will be administered to infants between their 8-27th days of life
|
|---|---|---|
|
Gastrointestinal disorders
Infantile hypertrophic pyloric stenosis
|
0.01%
1/10898 • 12 months
|
0.00%
0/10934 • 12 months
|
|
General disorders
Hospitalization within 28 d of treatment
|
0.13%
14/10898 • 12 months
|
0.06%
7/10934 • 12 months
|
|
General disorders
Mortality within 28 d of treatment
|
0.15%
16/10898 • 12 months
|
0.07%
8/10934 • 12 months
|
Other adverse events
| Measure |
Azithromycin
n=10898 participants at risk
a single dose of Azithromycin will be administered to infants between their 8-27th days of life
Azithromycin: a single dose of Azithromycin will be administered to infants between their 8-27th days of life
|
Placebo
n=10934 participants at risk
a single dose of placebo will be administered to infants between their 8-27th days of life
Placebo: a single dose of Placebo will be administered to infants between their 8-27th days of life
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting (any)
|
0.72%
78/10898 • 12 months
|
0.45%
49/10934 • 12 months
|
|
Gastrointestinal disorders
Vomiting after every feed
|
0.20%
22/10898 • 12 months
|
0.08%
9/10934 • 12 months
|
|
Gastrointestinal disorders
Projectile vomiting
|
0.03%
3/10898 • 12 months
|
0.00%
0/10934 • 12 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.47%
51/10898 • 12 months
|
0.56%
61/10934 • 12 months
|
|
General disorders
Fever
|
1.8%
193/10898 • 12 months
|
2.2%
237/10934 • 12 months
|
|
General disorders
Abdominal pain
|
1.9%
209/10898 • 12 months
|
1.6%
171/10934 • 12 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.64%
70/10898 • 12 months
|
0.79%
86/10934 • 12 months
|
|
Gastrointestinal disorders
Constipation
|
0.75%
82/10898 • 12 months
|
1.0%
111/10934 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place